Product Liability Prevention

SEMI S2/S8 (Safety/Ergonomics)

CE Mark Review

Hazard/Risk Analysis

Workplace/Facility Safety

Regulatory/Code Compliance

Semiconductor Equipment Safety

Construction Safety

Litigation Support

Fire Safety

Advertising/Marketing Review

EMC Compliance

Warning/Manuals

Recall Strategies

FDA Compliance

Medical Device Safety

Warranties/Disclaimers

 

 

 

 

 

Lewis Bass International has specialized in Product Liability Prevention for the past 29 years. We currently have associates around the world that include Attorneys, Mechanical Engineers, Electrical Engineers, Chemical Engineers, Industrial Engineers, Certified Industrial Hygienists, Certified Ergonomists, Safety Engineers, and technical writers.

What is unique about our business is we conduct evaluations and issue Preliminary Reports to our clients concerning their devices. With the Attorney/Client Privilege, we can alert our clients to problems, which they can correct, prior to our issuing a Final Report that is open to public view. The generated Safety Legal Reports or SEMI S2* or S8** or CE Reports*** can serve as valuable tools to present to your insurance agents to reflect your Reduced Product Liability Exposure.

These reports can also serve as valuable public relations, marketing and sales tools for your products and your company.

* SEMI S2 - Safety guidelines for semiconductor manufacturing equipment published by Semiconductor Equipment and Materials International (SEMI)

** S8 - Safety guidelines for Ergonomics/Human Factors published by SEMI.

*** CE Reports – Conformité Européenne - Safety and Technical requirements for Europe.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Safe Product Design]

[Environmental Safety]

[Medical Device Product Liability/GMP...]

[Automation/Robotic Safety]

[Liability Prevention Services]

[OSHA Compliance]

Warnings, Instructions & Manuals

Training, Workshops & Seminars

Software Safety

Semiconductor/Process Equip. Safety

Litigation Support Service

 

 

 

 

 

 

 

 

 

 

 

 

SAFE PRODUCT DESIGN
We identify and assess product hazards and recommend means to reduce exposure. We evaluate whether the risk of injury or property damage can be eliminated or reduced by redesign, guarding, instructions, warnings, or fail-safe design techniques.

WARNINGS, INSTRUCTIONS AND MANUALS
We review product instructions and manuals and determine where CAUTIONS and WARNINGS may be needed to alert users and maintenance personnel to product dangers. We assist manufacturing clients to develop and validate product warnings.

ENVIRONMENTAL SAFETY
We advise firms and audit their progress on environmental management projects. We have extensive experience with Federal, State and local environmental laws and regulations, and can analyze the extent of a firm's regulatory compliance in terms of product design, plant design and plant operations.

TRAINING WORKSHOPS AND SEMINARS
We offer workshops for all aspects of safety. We provide courses tailored to a firm's particular needs in training seminars. Our seminars and training programs increase employee awareness of their role in accident and liability prevention.
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MEDICAL DEVICE PRODUCT LIABILITY PREVENTION
AND GMP COMPLIANCE CAPABILITIES
Lewis Bass International, and its supporting engineering organizations provide comprehensive legal/safety consulting services to medical device manufacturers. We analyze medical devices and medical process and device software for product liability exposure, and hazards. We provide advise regarding FDA compliance.

We assist our clients by auditing their GMP programs. We assist our clients prepare their medical device Pre-Market Applications or 510(k) notifications. We develop complaint and MDR reporting guidelines and advise firms regarding recall strategy.

We help our clients obtain third party certification of their products by independent testing laboratories.
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SOFTWARE SAFETY
An increasing number of industrial processes and products are controlled by software. We analyze computer software for potential safety and regulatory concerns.
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AUTOMATION/ROBOTICS SAFETY
We use the system safety approach to analyze robotic and automation safety. We analyze the hazards associated with robots, including the possibility that a worker could be pinned, crushed, or burned.
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SEMICONDUCTOR PROCESS EQUIPMENT SAFETY
We perform third party hazard and liability analyses of semiconductor processing equipment to assess the interaction of users, workers and maintenance personnel with toxic gasses and materials, high voltages, and microwave and radio frequency radiation. Based on our analyses, improvements are suggested to increase the safety of the system and reduce potential liability.
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LIABILITY PREVENTION SERVICES
Services of  Lewis Bass International involving liability prevention cover a wide range of products, facilities and circumstances. We have demonstrated our ability to evaluate the safety and product liability aspects of a variety of systems for manufacturers. We have developed product risk checklists which are used by industry to evaluate the product liability risk of new products, including automated and computer controlled systems, prior to their market introduction.
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LITIGATION SUPPORT SERVICES
Our experience with and knowledge of the law, safety, engineering and management is routinely applied to products, the workplace, and the environment. We have the ability to integrate product, environmental and industrial safety law to assess the interaction of the workplace, product, environment and worker or user to determine accident causation and to reduce the risk of future liability.
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OSHA Compliance
A regulation was issued on February 24, 1992, by Federal OSHA regarding process safety management of highly hazardous chemicals (29 CFR 1910.119). The cornerstone of the new regulation is mandatory risk assessment using system safety techniques.

California legislation makes the safety of company personnel even more important than before. Under Cal/OSHA, an Injury/Illness Prevention Program (IIPP), including hazard identification, assessment and reduction is required. Our risk assessment work will complement your IIPP. Under California Penal Code 387, company management faces criminal penalties for employees exposed to concealed hazards that have not been made known to OSHA and/or the affected employees. Criminal liability for safety decisions is a concern of company management, not just in California, but nationwide.

In all states, an adequately documented and enforced safety program should significantly reduce product liability exposure, lower workers compensation claims, and reduce criminal liability exposure based on the safety of company employees.

We can assist you in complying with the OSHA regulations as it relates to your facilities. We are able to analyze the requirements of the regulation and provide a legal opinion as to the activities necessary for compliance. In addition, we can comment on the potential liability exposure associated with your operations and discuss our findings under attorney-client privilege.

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Phone: (408) 374-4453
Fax: (408) 374-0295